The Maine Board of Pharmacy voted unanimously Aug. 3 to approve rules allowing pharmacists to dispense the overdose antidote naloxone without a prescription, but Gov. Paul LePage has not signed off on the regulations five months later. Associated Press/Toby Talbot

AUGUSTA — Gov. Paul LePage continues to block new rules allowing Mainers to obtain an overdose reversal drug without a prescription, five months after regulators approved the policy to help reduce the state’s record number of opioid-related deaths.

The Maine Board of Pharmacy voted unanimously Aug. 3 to approve rules allowing pharmacists to dispense the lifesaving drug naloxone without a prescription. Also known by its trade name Narcan, naloxone has been used thousands of times in Maine in recent years to revive patients suffering from the potentially deadly effects of an overdose from heroin, fentanyl or other opioids.

Advocates contend that making naloxone available without a prescription – as is the case in more than 40 states – would help increase availability of the reversal drug at a time when the state is struggling to deal with an unprecedented drug crisis killing an average of one Mainer a day.

LePage spokeswoman Julie Rabinowitz said Friday the rules are still in the governor’s office, pending review. Rabinowitz declined to provide any additional comment or explanation regarding the delay. LePage has consistently opposed the policy, claiming several times that it could provide a false sense of security that only perpetuates opioid abuse.

Yet the lack of statewide rules makes Maine a national outlier, even though the state had the nation’s seventh-highest surge in drug overdose deaths between 2015 and 2016, according to U.S. Centers for Disease Control and Prevention data.

The delayed rules are also sowing confusion within the pharmacy industry.

While national retailer Walgreens is already dispensing naloxone without a prescription in Maine, the CVS chain is holding off for now. That makes Maine one of just four states nationally where CVS customers cannot obtain the drug without a doctor’s order.

“It is our reading of the law that these regulations need to be finalized to develop the appropriate protocol for pharmacists to dispense naloxone to patients without an individual prescription in Maine,” a representative of CVS Health said in a written statement.

This is only the latest delay in a policy that was approved by state lawmakers more than a year and a half ago. And frustrations are rising among those who view over-the-counter naloxone as a small but important component of Maine’s multifaceted attempts to deal with the opioid crisis.

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“The pharmacy board drafted rules and, as far I know, they are sitting on the governor’s desk. They’ve been there for months,” said Attorney General Janet Mills, a frequent critic of LePage who is seeking the Democratic nomination for governor. “The rules have not been promulgated, and I’m not sure why. But we need to have naloxone available without prescription – formal prescription – and available to families of people who need it.”

Maine reported 376 drug overdose deaths in 2016, more than double the number just three years earlier. The Attorney General’s Office has not finalized the numbers for 2017 yet, but Maine was still averaging more than one overdose death a day for the first six months of last year. For the past several years, the vast majority of deaths were caused by heroin, the powerful synthetic opioid fentanyl or a mix of opioids.

Police officers and emergency medical services crews statewide routinely carry naloxone and have become skilled at its administration, with cities such as Portland occasionally reporting more than a dozen overdose calls in a day. Although figures for 2017 were not yet available, emergency personnel administered naloxone 2,380 times in 2016, compared with 1,585 times the year before.

Mills, whose office used legal settlement funds to purchase naloxone for police departments around the state, told the Legislature’s Health and Human Services Committee that those kits have been used to revive 307 people as of late December 2017.

When administered in a timely fashion, naloxone can quickly reverse the effects of an overdose – such as arrested breathing – by attaching to the opioid receptors in the brain. It is typically administered via nasal spray or auto-injector pen.

Lawmakers originally approved making naloxone available over the counter in April 2016 and easily overrode a LePage veto. But the Board of Pharmacy sent the issue back to the Legislature because members said some aspects of the language crafted by lawmakers was unclear. An amended bill passed both the House and Senate with overwhelming support – unanimously in the Senate and on a 126-20 vote in the House – last June and became law without the governor’s signature.

Rep. Karen Vachon, a Scarborough Republican who sponsored last year’s amended bill, said she has yet to learn from the governor’s office why LePage hasn’t acted on the rules. She hopes to meet with the governor now that the Legislature is back in session.

“It’s very important,” said Vachon, who served on a recently concluded Opioid Task Force examining the state’s response to the crisis. “This is about saving lives, so I am a bit befuddled as to why it has been held up. I don’t have any clarity as to the reason why.”

LePage has angered some in the drug treatment community with what they view as insensitive – and inaccurate, some argue – statements about naloxone.

“Naloxone does not truly save lives; it merely extends them until the next overdose,” LePage wrote in his veto letter for the original 2016 bill. “Creating a situation where an addict has a heroin needle in one hand and a shot of naloxone in the other produces a sense of normalcy and security around heroin use that serves only to perpetuate the cycle of addiction.”

PHARMACIES LEFT CONFUSED

Maine is one of only a handful of states – and the only one in the entire Northeast – without either a statewide “standing order” issued by the state’s top physician or rules allowing dispensation of naloxone without a prescription.

In the meantime, there appears to be some confusion about whether pharmacies can take steps on their own to dispense naloxone over the counter.

Some pharmacies, including the Walgreens chain, have obtained a “standing order” in which a licensed physician authorizes pharmacists to dispense the drug to people who meet certain criteria, depending on the order.

“Walgreens is able to dispense the medication in all our Maine pharmacies without requiring the individual to first obtain a prescription from a prescriber,” wrote Allison Mack, a spokeswoman for the Illinois-based chain.

Mack noted that naloxone is still kept behind the pharmacy counter and is, therefore, not technically an over-the-counter product. Mack said pharmacists provide instructions to recipients on proper use of naloxone, including to call 911 regardless because “Narcan is not a substitute for medical care and anyone who is administered the medication should seek immediate medical attention.”

CVS, meanwhile, is waiting for the rules to emerge from LePage’s office.

“We are keeping in touch with Maine’s Board of Pharmacy to track the progress of their rulemaking for regulations that will allow naloxone to be dispensed to a patient without requiring an individual prescription,” a spokesman said.

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